Reported May 27, 2020 · Terminated
Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The…
Innovasis, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Innovasis, Inc · 614 E 3900 S · Salt Lake City, UT · 84107-1902
Is this the product you have?
- Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx
- Cervical Plate System - Product UsageThe Cervical Plate System is intended for use in anterior cervical fixation
- Lot codes and dates
- Serial numbers
233923402346235123522354
- Serial numbers
- Amount recalled
- 6
Where it was sold
Why it was recalled
Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled as "Variable" should be labeled as "Fixed. If user installs a fixed rescue screw instead of variable, the screw head may not be flush, it could back out, which could interfere with the cover screw.
This product could cause temporary or reversible health problems — stop using it.
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